Accutane Side Effects/Legal Information
Recent studies have linked Accutane (known generically as Isotretinoin), a popular acne medication, to serious and painful gastrointestinal problems such as inflammatory Bowel Disease (IBD). IBD is often characterized by conditions such as Ulcerative Colitis and Chron’s disease, and is associated with an increased risk of developing colorectal cancer. Bailey Perrin Bailey is currently investigating potential lawsuits involving current or former users of Accutane who have developed serious gastrointestinal side effects. If you or a loved one has taken Accutane and suffered serious gastrointestinal side effects, please contact Bailey Perrin Bailey immediately for a free evaluation, our lawyers may be able to help you seek compensation for your injuries.
Gastrointestinal Side Effects Associated with Accutane include, but are not limited to the following:
- Inflammatory Bowel Disease (IBD)
- Crohn’s Disease
- Ulcerative Colitis.
In addition, scientific studies have suggested Accutane may cause the following:
- Serious mental health problems (depression, psychosis, suicide)
- Birth defects, miscarriages, premature births
- Stevens-Johnson Syndrome from Accutane (severe skin reaction, sometimes fatal).
Over 16 million people worldwide have used Accutane since it was first approved by the FDA in 1982. Accutane is used for treatment of severe acne that is unresponsive to conventional therapy, including antibiotics. On June 26, 2009, Hoffman-La Roche Pharmaceuticals, the manufacturer of Accutane, voluntarily pulled the drug from the U.S. market citing among others reasons the cost of defending Accutane injury lawsuits. Accutane continues to be available as a generic and is also sold under a wide variety of names including:
Accutane Verdicts and Settlements
In some cases, allegations about Hoffman-La Roche’s failure to warn of Accutane’s serious and painful gastrointestinal problems have led to jury awards of millions of dollars. As of February 2010, all six plaintiffs bringing Accutane IBD lawsuits against the drug maker have won (one judgment has been overturned by a Florida appeals court). Hundreds of cases are still pending in both State and Federal Courts.
What is Accutane and What Is It Used To Treat?
Accutane is a member of a family of drugs called retinoids. It is a form of Vitamin A and is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
Who Should Not Take Accutane?
- Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects.
- Do not take Accutane if you are breastfeeding
- Do not take Accutane if you are allergic to anything in it. Accutane contains parabens as the preservative and may interfere with the body’s endocrine system.
- Tell your doctor about all your health conditions before taking Accutane, especially if you have mental problems, asthma, liver disease, diabetes, heart disease, bone loss (osteoporosis) or weak bones, an eating problem called anorexia nervosa (where people eat too little), food or medicine allergies.
Are There Any Interactions With Drugs or Foods?
Accutane may interact with other medicines sometimes causing serious side effects. Tell your healthcare professional about all medicines (prescription and non-prescription), vitamins, and herbal supplements you take. Especially tell your doctors if you take Vitamin A, Tetracycline antibiotics, Progestin-only birth control pills (mini pills), Dilantin, Corticosteroids, St. Johns Wort.
Accutane Side Effects?
All medicines have the potential to cause side effects. Luckily, many individuals have no, or minor, side effects when using Accutane. However, if a problem persists, becoming particularly bothersome there may be a more serious underlying medical problem. In those circumstances it is imperative that you seek immediate medical assistance.
Common side effects when using Accutane include, but are not limited to the following:
- Abnormal hair growth; abnormal skin sensations; bleeding and redness or swelling of the gums; changes in menstrual flow; chapped lips; decreased tolerance to contact lenses; dizziness; dry eyes and mouth; dry nose that may lead to nosebleeds; dry or peeling skin; fatigue; flushing; general body discomfort; hair thinning; headache; itching; lack of energy; nervousness; respiratory tract infection; sleeplessness; sweating; temporary worsening of acne; voice changes.
Serious side effects when using Accutane include, but are not limited to the following:
- Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre, aggressive, or violent behavior; bowel pain; chest pain or pounding in the chest; dark urine; depression; difficult or painful swallowing; difficulty moving; excessive thirst or urination; fainting; fast heartbeat; fever; fractured or weak bones; hearing problems or ringing in the ears; increased pressure in the brain (pressure in the eye; nausea; vision changes; vomiting); joint or back pain; leg swelling; muscle weakness with or without pain; nausea; new or worsening heartburn; rectal bleeding; red patches or bruises on the legs; shortness of breath; seizures; severe birth defects; severe diarrhea; severe headache; skin infection; slurred speech; stomach pain or tenderness; stroke; stunted growth in children; sun sensitivity; swelling of the pancreas (fever; increased heartbeat; nausea; stomach tenderness; vomiting); swollen glands; thoughts of suicide; tightness in the lungs; vision changes; vomiting; weakness; yellowing of the skin or eyes.
Read more: http://www.drugs.com/sfx/accutane-side-effects.html
Accutane Related Gastrointestinal Problems and Other Serious Side Effects:
Inflammatory Bowel Disease (IBD)
People suffering from Accutane related Inflammatory Bowel Disease (IBD) , can feel the effects of the drug many years after using the medication. IBD is a general term that refers to a group of digestive disorders that can cause chronic inflammation or redness and swelling in the small and large intestines. Symptoms of IBD range from mild to severe, and may come and go. They often include abdominal pain and cramping, weight loss, poor appetite, fatigue, diarrhea (can be bloody), rectal bleeding and fever. Other IBD related health problems may include: arthritis and joint pain, weak bones and bone breaks, eye inflammation, liver inflammation, gallstones, skin ulcers or lesions, kidney stones, delayed puberty and growth problems (in children and teens), and in rare cases, lung problems.
The two major types of IBD are Crohn’s disease and ulcerative colitis. Although they share similar symptoms they differ in that they affect different parts of the digestive tract.
Crohn’s Disease and Ulcerative Colitis
Crohn’s disease results in inflammation which usually affect all layers of the intestinal wall in the small and large intestines, as well as other digestive organs. In contrast, ulcerative colitis results in inflammation and ulcers (sores) which usually affect the inner lining of the large intestine (colon) and rectum. The big difference between the two being Crohn’s causes inflammation deeper within the intestinal wall whereas ulcerative colitis affects only the superficial top layer of the lining of the large intestine. There is no cure for either disease and if drug therapy fails, which it often does, in treating these ailments then surgery is the only viable option.
Other Serious Side effects:
Accutane is known to have a wide array of adverse effects some more serious than others:
- In February 2010, Health Canada reported that it had received post-marketing reports of severe skin reactions, including a sometimes fatal reaction known as Stevens-Johnson Syndrome, associated with Accutane use. A review of Hoffmann-La Roche’s global safety databases (as of November 6, 2009) revealed 66 cases of severe skin reactions in adults and children possibly caused by Accutane use. Of the 66 cases, two were fatal.
- Psychiatric problems such as depression, psychosis and suicides have been reported. The FDA has received thousands of reports of various psychiatric problems. More importantly, the FDA has received over a hundred reports of suicide linked to the use of Accutane.
- The most severe side effects include the increased risk of miscarriages, infant deaths, and severe birth defects, such as fetal malformations, mental retardation, heart defects, and facial abnormalities. As previously mentioned, Accutane belongs to a class of chemicals called “retinoids,” which are some of the most potent teratogens in humans today. A teratogen is an environmental or chemical factor that is capable of causing birth defects. Accutane is classified as FDA Pregnancy Category X and its use is contraindicated in pregnancy. There is an increased risk of birth defects in fetuses of women taking Accutane during their first trimeseter. Therefore, Accutane should be avoided at all costs during pregnancy.
Accutane FDA Warning
The Food and Drug Administration required an Accutane FDA warning in the form of a black box label. It is the strongest warning that the FDA requires. A black box warning indicates that studies have found that Accutane carries a significant risk of serious or even life-threatening adverse effects. The FDA required Hoffman-La Roche to place a black box warning on the labeling of Accutane, or in literature describing it to help patients avoid serious adverse events.
In addition, the FDA now has stricter rules regarding the dispensation of Accutane. Doctors are required to get signed consent forms from patients acknowledging that they are aware of and understand all the risks associated with Accutane, including and not limited to those already mentioned above. Pharmacists must also provide patients with appropriate educational materials, a detailed warning brochure from the FDA, called a Medguide (see link below).
For more additional important information about Accutane please visit: http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085812.pdf